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Preventing Lack of Iodine During Pregnancy

Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy

Intervention: potassium iodide (Drug); placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: University Hospital, Toulouse

Official(s) and/or principal investigator(s):
CARON PHILIPPE, Pr, Principal Investigator, Affiliation: CHU Toulouse
WEMEAU Jean-Louis, Pr, Study Chair, Affiliation: CHRU LILLE
NICCOLI-SIRE Patricia, Pr, Study Chair, Affiliation: CHU Timone MARSEILLE
BRUCKER-DAVIS Francoise, Dr, Study Chair, Affiliation: CHU Nice

Summary

The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.

Clinical Details

Official title: Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Supplying a daily dose of 200 µg of potassium iodide in comparison with a placebo dose to pregnant woman and evaluate the impact on neuro-cognitive development of children followed up until two years

Secondary outcome:

Prevalence of hypothyroxinemia and hypothyroidism during pregnancy

Change in the functional thyroid parameters of mother during iodine treatment

Comparison of the psychometric development of children , for woman with and without treatment

Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment

Detailed description: 374 patients with pregnancy less 12 weeks amenorrhea Patients randomized in 2 parallel groups (each group with 187 patients)

- one group with 200 µg of potassium iodide

- one group with placebo

Follow up during 3 years with :

- a selection visit, an inclusion with randomization before 12 weeks amenorrhea

- and follow up visit at the 5th month and 8th month of pregnancy, the day of birth, and

6, 12, and 24 months " post partum "

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Patients with pregnancy less 12 weeks amenorrhea , with clinically normal pregnancy,

unique or twiny

- Patients who agree to take part in the study and able to sign an Informed Consent

Form Exclusion Criteria:

- Patients receiving a treatment for thyroid affection, or with thyroid pathology

- Patients with a chronic pathology like insulin dependent diabetes or arterial

hypertension

- Patients with a treatment supplying iodine or having had a gynecologic exam with a

iodine solution in the last 30 days

- Patients taking part in another clinical test or in the last 30 days

- Patients with depressive antecedent before pregnancy or taking antidepressant

treatment

- Psychiatric troubles that may interfere with the clinical evaluation

- Patients under special supervision or trusteeship

- No social security cover

Locations and Contacts

Endocrinology - University Hospital, Toulouse 31059, France
Additional Information

Related publications:

Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Réssigeac P, Vertongen F, Grangé V. Urinary iodine excretion during normal pregnancy in healthy women living in the southwest of France: correlation with maternal thyroid parameters. Thyroid. 1997 Oct;7(5):749-54.

Caron Ph, D Glinoer La fonction thyroïdienne au cours de la grossesse La Thyroïde. De la physiologie cellulaire aux dysfonctionnements. Des concepts à la pratique. Ed Expansion Scientifique - Paris, 2001, 495-500.

Starting date: December 2006
Last updated: October 10, 2011

Page last updated: August 23, 2015

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